510(k) Report

Devices descending from K013475

216 later devices reach Trident Porous Titanium Acetabular Component with Peri-Apatite Coating through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202472ACTIS Duofix Hip ProsthesisDePuy Orthopaedics, Inc.202015—
+7K193398Summit DuoFix HA CoatingDePuy Orthopaedics, Inc.202020—
+7K160907DePuy Actis DuoFix Hip ProsthesisDepuy (Ireland)201626—
+8K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…Nextstep Arthopedix, LLC20260—
+8K250477NextAR (TM) SpineMedacta International S.A.20250—
+8K250108OptiVu™ ShoulderMr Surgical Solutions, LLC20251—
+8K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC20251—
+8K243977EMPHASYS Acetabular SystemDepuy Ireland UC20251—
+8K242084EMPHASYS Acetabular Shell with RapiTite HADepuy Ireland UC20240—
+8K232280NextAR™ TSA PlatformMedacta International S.A.20231—
+8K223769NextAR™ Spine PlatformMedacta International S.A.20232—
+8K221104Actera™ hip systemConformis, Inc.202211
+9K252067Velora Acetabular SystemRestor3D, Inc.20250—
+9K252170OptiVu™ ShoulderMr Surgical Solutions, LLC20250—
+9K233172NextAR™ Spine PlatformMedacta International S.A.20241—
+9K231178ACTERA™ hip systemConformis, Inc.20230—